Covance Medical Director / Sr. Medical Director - Rheumatology / Inflammatory - US or EU based in Rome, Italy

Job Overview

The primary role of the incumbent will be to serve as a physician providing subject matter and drug development expertise. He/She will be expected to be a key contributor to the medical strategy and execution of clinical programs. Furthermore, the Sr. Medical Director will play a key role in people leadership/management, client relations, and business development representing Covance in proposals and industry meetings as needed.

This is a remote home-based role with up to 40% global travel.

Incumbent can be either US or EU based.

Company Focus

  • Contributes to the development of Company policies involving medical, safety and therapeutics

  • Participates in process improvement activities across Company

Client Relationship & Business Development Activities

  • Partnering with GCO to develop new and enhance existing client relationships where possible

  • Provides leadership and presents medical/scientific capabilities to clients as a participant of a proposal team

  • Leverage known and builds new relationships with investigators/sites to performs site/investigator feasibility and to support optimal recruiting and conduct of trials

  • Able to present or serve on panels to represent the company at conferences and scientific meetings.

Managerial

  • May provide mentoring to and be responsible for the oversight, career development and evaluation of Clinical Research Physicians, Associate Medical Directors and Medical Directors

  • Supports and participates in the recruitment process for department positions

  • Involved in assignment of projects and specific duties to direct reports

  • Responsible for administration and/or delegation of activities of his/her direct reports (for example PTO, timesheet and expense approval)

Leadership

  • May provide leadership to staff within the therapeutic area

  • Leads initiatives that impact and involves physicians within and across the TA

  • May contribute to vision and strategy/direction for therapeutic areaTherapeutic and Scientific Expertise

  • Develops training modules and materials, and provides training in disease states and protocol specific requirements across the Company

  • Participates in training opportunities to advance knowledge of drug development and good clinical practice guidelines

People Responsibilities

  • Serves as global lead project physician and can serve as a program level physician across multiple indications for a given company

  • Provides subject matter and drug development expertise to be a key contributor to the medical strategy and execution of the program for the client

  • Performs medical data review - Reviews laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed

  • Develops, reviews and revises protocols, case report forms, training materials, project specific tools, analysis plans design, clinical trial reports and new drug applications

  • Prepares materials for investigator meetings

  • Actively participates in investigator meetings

  • Provides medical/scientific expertise to project teams

  • Responsible for medical and safety monitoring on assigned projects

  • Interacts with inter-departmental and external consultants as appropriate

  • Participates in feasibility discussions relating to specific project proposals

  • Participates in project risk assessment activities

  • Assists when needed with data safety monitoring board activities

  • Provides clinical and medical expertise to other Covance departments

  • Contributes to the scientific strategic leadership for a given therapeutic area

Education/Qualifications

  • MD degree

  • Specialization in Rheumatology, Immunology, Inflammatory, or Autoimmune disease is highly desired

  • Relevant sub specialty fellowship training

  • History of Board Certification

Experience

  • Minimum of 5 years clinical research experience

  • Experience in and specialization in Rheumatology, Immunology, Inflammatory, or Autoimmune disease is highly desired

  • Substantial knowledge of drug development and extensive clinical research experience within the pharmaceutical/CRO industrysupporting Phase I - IV clinical trials

Job Number 2018-20731

Job Category Hidden (23502)

Position Type Full-Time

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